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 Expert  721920

Expert in Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals

Available for your Consulting and Expert Witness Needs

Virginia (VA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst, an editor of various analytical manuals, as a Chief Chemist in charge of supervising review chemists/microbiologists in the review and approval of CMC sections for veterinary drug products. His last position was that of Staff Scientist for Manufacturing and Quality Control on the Generic Animal Drug and Quality Control Staff in the Center for Veterinary Medicine. Expert served as a member of the USP Revision Committee from 1980 to 1990. He has served as a member of the AFIA Aquaculture Committee and Working Group (1993-1996).

Food and Drug Administration


Chemistry, Manufacturing and Controls

Since 1992 he has worked as a consultant to the pharmaceutical industry for human and veterinary products. He is knowledgeable in the development of SOPs for GMP operations (human, veterinary and animal products), stability and method validation protocols. He has conducted GMP audits of bulk pharmaceutical chemicals (APIs) and dosage form manufacturing sites and operations, both foreign and domestic. He has also conducted GLP audits. Now he focuses on providing advice and assistance in the areas of human drugs and devices, and veterinary products. Particular focus is given to areas of GMPs, audits and regulatory affairs.

Good Manufacturing Practice


standard operating procedure


veterinary medicine


Food and Drug Administration regulation


Food and Drug Administration compliance


Food and Drug Administration National Drug Code

As a Staff Scientist at the Office of New Animal Drug Evaluation Center for Veterinary Medicine, he helped to develop international and FDA-industry Guidelines, he coordinated the Office-FDA Field/Foreign Inspections of Veterinary Manufacturing sites, and the CVM-Field Bio-Monitoring Research Activities. He also provided guidance in the review of Animal Drug Applications.

From 1975 to 1990, he was the Manager of the Manufacturing and Quality Control Unit in the Division of Chemistry in the Office of the Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. There, he managed the reviews of manufacturing sections of New Animal Drug Applications, provided Quality Control to assure consistency of review, met with industry representatives to discuss applicable sections of NADA submissions, developed of guideline (stability and manufacturing) and conduct of training, and was Co-Editor of the Animal Drug Analytical manual.


animal drug testing


veterinary pharmacology

As an Analytical Chemist in the FDA Cincinnati District Office, he conducted analyses of human (pharmaceutical) and veterinary (pharmaceutical and medicated feeds) drugs, foods for food additives, pesticides in foods, drug residues, controlled and narcotic drugs, hazardous substances; and conducted research into the development of methods for laboratory use.

food additive




pesticide toxicity

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Baltimore, Maryland;  Frederick, Maryland;  Gaithersburg, Maryland;  Bowie, Maryland;  Richmond, Virginia;  Alexandria, Virginia;  Wilmington, Delaware;  and Lancaster, Pennsylvania.

Degree   Subject   Institution  
BS   Chemistry   Wheeling Jesuit University  
  Graduate Study-Advanced Chemistry   Cincinnati University  
  Advanced Analytical Chemistry   Georgetown University  
  Food and Drug Law   George Washington University  

Work History:
Years   Employer   Department   Title   Responsibilities

1997 to


(Undisclosed Consulting Company)



Senior Consultant


Responsibilities include providing advice and assistance in the areas of human drugs and devices, and veterinary products. Particular focus is given to areas of GMPs, audits and regulatory affairs.

1996 to 1997


Independent Conultant



Consultant to the Pharmaceutical Industry


Responsibilities included providing advice and assistance in the areas of regulatory affairs, cGMP requirements, development of SOPs and validation protocols.

1992 to 1996


PennField Oil Co., Omaha, Nebraska



Vice President for Government and Regulatory Affairs


Responsibilities included overseeing that operations at POC complied with FDA, EPA, and OSHA regulations; developing of SOPS and protocols; conducting visits of Foreign manufacturers (APIs) of POC products; conducting mock inspections of POC site and New Drug Substance manufacturing sites.

1990 to 1992




Office of New Animal Drug Evaluation Center for Veterinary Medicine


Staff Scientist, Manufacturing and Quality Control Generic Animal Drug and Quality Control Staff


1975 to 1990


Center for Veterinary Medicine, FDA


Division of Chemistry in the Office of the Director, Office of New Animal Drug Evaluation


Manager (Branch Chief, Supervisory Chemist and Chief Chemist)


1967 to 1975




Division of Field Operations in the office of the Executive Director for Regional Operations


Scientific Coordinator–Chemist in the Field Sciences Branch


Responsibilities included coordinating/managing analytical activities of FDA field Scientists relative to the conduct of responsible FDA field and headquarters program activities: coordinating analytical methodology and quality control functions; coordinate test of new human and veterinary drugs and food additives as presented in formal applications; conducting training exercises and developing methodology as needed; editing of Food Additive and Animal Drug Analytical manuals.

1962 to 1967




Cincinnati District Office


Analytical Chemist


Career Accomplishments:

He is a member of the American Chemical Society, the Parenteral Drug Association, and the Regulatory Affairs Professional Society.

Publications and Patents Summary

He is the author of several publications.

Selected Publications and Publishers  
 - Third Int'l Consulation on Veterinary Products  
 - Journal of Pharmaceutical Sciences  
 - Journal of the Association of Official Agricultural Chemists (JAOAC)  

Government Experience:
Years   Agency  
1962 to 1992   FDA  

Consulting Services:
Recent Client Requests:
  • Veterinary drug FDA expert for consultation on topical antimicrobial for non-food animals.
  • Expert in NADA and ANADA regulations and submission experience for LVP drug products.
  • FDA expert for consultation to provide pre approval and post approval support to ensure approval of a NADA with a minimum of time spent in the review cycle of T-rex.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Expert in animal pharmaceutical veterinary research needed for consulting on commercial viability of a pending patent relating to a method of delivering medicates to cows.
  • Expert in animal products for consulting on registering a new product.
  • Veterinary litigation expert for consulting on proheart 6/moxidectin case.
  • Animal pharmacology expert for consulting on animal pharmacology.
  • Expert for consulting on flea & tick treatment in litigation case.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.


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